Epanova

Before taking Epanova, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Epanova or to any of its ingredients
• have thyroid problems
• have diabetes
• have liver disease
• have pancreatic disease
• are allergic to fish or shellfish
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X - are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Epanova falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• how you respond to this medication

The recommended dose of Epanova for the treatment of high triglycerides is 2 grams (2 capsules) or 4 grams (4 capsules) once daily, depending on your body's response and how well the medication is tolerated.

If you take too much Epanova, call your healthcare provider or local Poison Control Center or seek emergency medical attention right away.

If Epanova is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

Monitoring: Laboratory Tests

In some patients, Epanova increases LDL-C levels. LDL-C levels should be monitored periodically during therapy with Epanova.

In patients with hepatic impairment, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be monitored periodically during therapy with Epanova.

Fish Allergy

Epanova contains polyunsaturated free fatty acids derived from fish oils. It is not known whether patients with allergies to fish and/or shellfish, are at increased risk of an allergic reaction to Epanova. Epanova should be used with caution in patients with known hypersensitivity to fish and/or shellfish.

Epanova, a lipid-regulating agent, is a coated soft-gelatin capsule containing 1 gram of fish oil-derived free fatty acids, designated “omega-3-carboxylic acids,” with at least 850 mg of polyunsaturated fatty acids, including multiple omega-3 fatty acids (eicosapentaenoic acid [EPA] and docosahexaenoic acid [DHA] being the most abundant).

The empirical formula of EPA free fatty acid is C20H30O2, and the molecular weight of EPA free fatty acid is 302.45. The structural formula of EPA free fatty acid is:

The empirical formula of DHA free fatty acid is C22H32O2, and the molecular weight of DHA free fatty acid is 328.49. The structural formula of DHA free fatty acid is:

Epanova capsules also contain the following inactive ingredients: 3 mg α-tocopherol (in a carrier of vegetable oil), and porcine Type A gelatin, glycerol, sorbitol, and purified water (components of the capsule shell). Coating and ink components to the Epanova capsules also contain ethyl acrylate and methyl methacrylate copolymer dispersion, talc, titanium dioxide, iron oxide red, polysorbate 80, and carboxymethylcellulose sodium (coating components), pharmaceutical glaze, titanium dioxide, n-butyl alcohol, propylene glycol and isopropanol (ink components).

Severe Hypertriglyceridemia

The effects of Epanova in severe hypertriglyceridemia were assessed in a 12-week randomized, placebo (olive oil)-controlled, double-blind, parallel-group trial. After a wash-out period of lipid-altering medications other than statins and ezetimibe, patients whose TG levels were between 500 and 2,000 mg/dL were randomly assigned to placebo or Epanova 2, 3, or 4 grams per day. Overall, the median baseline triglyceride level was 694 mg/dL. Median baseline non-HDL-C, LDL-C, and HDL-C levels were 217 mg/dL, 81 mg/dL, and 28 mg/dL, respectively. The study population was mostly Caucasian (92%) and male (77%). The mean age was 52 years and the mean BMI was 31 kg/m2. Thirty-seven percent of patients had diabetes, 35% were treated with a statin and/or ezetimibe, and 29% had baseline TG > 885 mg/dL.

Treatment with Epanova led to statistically significant reductions in fasting TG levels (Table 2). Treatment with Epanova also resulted in statistically significant reductions in non-HDL-C levels compared with placebo, but increased LDL-C levels (Table 2).

The effect of Epanova on the risk for pancreatitis has not been determined.

The effect of Epanova on cardiovascular mortality and morbidity has not been determined.

Epanova may cause serious side effects, including:

• increases in the results of blood tests used to check your liver function (ALT and AST) and your bad cholesterol levels (LDL-C)
• possible allergic reactions if you are also allergic to fish or shellfish

The most common side effects include:

• diarrhea
• upset stomach
• abdominal pain or discomfort
• burping

This is not a complete list of possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Epanova is a red/brown, soft gelatin capsule with imprint OME1.

• Store Epanova at room temperature between 68°F to 77°F (20°C to 25°C).
• Do not freeze.
• Keep all medicines out of the reach of children.

Applies to omega-3 polyunsaturated fatty acids: oral capsule, oral delayed release capsule, oral kit, oral liquid, oral tablet chewable

Gastrointestinal

Common (1% to 10%): Eructation, dyspepsia, nausea, gastrointestinal disorders (including abdominal distension, abdominal pain, constipation, diarrhea, flatulence, gastroesophageal reflux disease, vomiting)
Uncommon (0.1% to 1%): Gastrointestinal hemorrhage, gastroenteritis
Rare (less than 0.1%): Gastrointestinal pain
Very rare (less than 0.01%): Lower gastrointestinal hemorrhage[Ref]

General

The most common adverse events were eructation, dyspepsia, and taste perversion[Ref]

Other

Common (1% to 10%): Infection, pain
Uncommon (0.1% to 1%): Death[Ref]

Dermatologic

Common (1% to 10%): Rash
Uncommon (0.1% to 1%): Atopic dermatitis
Rare (less than 0.1%): Urticaria, acne, rash pruritic
Frequency not reported: Pruritus[Ref]

Cardiovascular

Uncommon (0.1% to 1%): Hypotension[Ref]

Musculoskeletal

Common (1% to 10%): Back pain[Ref]

Metabolic

Uncommon (0.1% to 1%): Hyperglycemia, gout, high triglycerides
Very rare (less than 0.01%): Blood lactate dehydrogenase increased[Ref]

Nervous system

Common (1% to 10%): Taste perversion
Uncommon (0.1% to 1%): Dizziness, dysgeusia, headache, hyperactivity[Ref]

Respiratory

Uncommon (0.1% to 1%): Epistaxis
Very rare (less than 0.01%): Nasal dryness
Frequency not reported: Influenza[Ref]

Hypersensitivity

Rare (less than 0.1%): Hypersensitivity
Postmarketing reports: Anaphylactic reaction[Ref]

Hematologic

Very rare (less than 0.01%): White blood count increased,
Frequency not reported: Slight prolongation of bleeding time
Postmarketing reports: Hemorrhagic diathesis[Ref]

Psychiatric

Uncommon (0.1% to 1%): Tics, tantrum, insomnia[Ref]

Hepatic

Rare (less than 0.1%): Liver disorders (including increased ALT, increased AST, and transaminases increased)[Ref]

Some side effects of Epanova may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.